MAUDE Adverse Event Report: CONMED CORPORATION VCARE; CANNULA, MANIPULATOR/INJECTOR, UTERINE

Model Number 60-6085-200A

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 08/02/2021

Event Type  malfunction  

Event Description

Multiple attempts to use the vcare (uterine manipulator) device but they malfunctioned twice.The surgeon had to use a total of three vcare devices to utilize an appropriately functioning device.The first two vcare devices used were leaking.

• Brand Name: VCARE
• Type of Device: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept boulevard; largo FL 33773
• MDR Report Key: 12369897
• MDR Text Key: 268251313
• Report Number: 12369897
• Device Sequence Number: 1
• Product Code: LKF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60-6085-200A
• Device Catalogue Number: 60-6085-200A
• Device Lot Number: 202103291 AND 202105031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/12/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/26/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 16060 DA
• Patient Weight: 89